Surgical Devices and Methods

ABSTRACT

Surgical devices having a plurality of outwardly-biased flexible fins capable of inward movement such that the fins converge to provide both a passageway for surgical instruments to traverse towards a surgical site, and provide a substantially impermeable seal, thus providing for fluid retention during the surgical procedure. The outwardly-biased flexible fins provide for soft tissue compression, decreasing the length of the lumen or passageway through which instruments pass, allowing for a wider range of movement of instruments and better access to the surgical site, especially in patients with greater amounts of fat tissue that would otherwise require longer lumen lengths in prior art endoscopic cannulas.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT

Not Applicable

INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC

Not Applicable

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to devices for performing percutaneousarthroscopic and other endoscopic or laparoscopic surgeries and, morespecifically, to surgical devices such as cannulas and “portal holderdevices” having a plurality of biasing fins that converge to define aflexible opening that is capable of closing to form a substantiallyimpermeable seal, and surgical device deployment tools for thedeployment of such devices during a surgical procedure. Theaforementioned convergence of the fins, in one embodiment, occurs duringinsertion proximally to limit fluid leakage when not being utilized anddiverge distally to retract soft tissues and improve visualization. Thisconcept utilizes, in addition to the features of the devices discussedherein, the inherent soft tissue and hydrostatic pressure to limitleakage. Numerous open (non-arthroscopic) applications also exist forthis invention in that the low-profile insertion of the biasing finsimproves surgical exposure and visualization. In open applications, thebiasing fins have greater divergence for direct visualization.

2. Description of Related Art Including Information Disclosed Under 37CFR 1.97 and 1.98

Traditional minimally-invasive arthroscopic surgeries are performedusing a cannula device to penetrate small incisions in the patient'sskin and outer tissue, creating a port through which surgical tools maybe passed to allow access to the underlying structure of interest. Forexample, in shoulder arthroscopy, the procedure is performed through“portals” in the patient's skin. These portals are formed from smallincisions, generally about ½ of an inch to an inch long in the skin, andare located over particular areas of the joint that the surgeon willneed to operate upon. Cannulas are then inserted into the portals sothat instruments can easily be placed in the shoulder joint. Shoulderarthroscopy itself involves inserting a specially designed video camerawith a fiber optic light source into the shoulder joint so that theanatomic structures of the joint can be seen. Instruments that have beenspecially designed to remove inflamed tissue, attach sutures to bone,and repair torn tendons and ligaments are then used to operate insidethe shoulder.

The area between the skin tissue and shoulder joint is quite small.Consequently, it is necessary to “inflate” the area by pumping anirrigation fluid (e.g. saline) into the joint under pressure. Inlaparoscopic surgical procedures, carbon dioxide in gaseous form may beutilized as an insufflating agent to perform a similar function. Thepressure produced by the irrigation fluid pushes the tissue outward fromthe joint and allows greater room for manipulation of the arthroscopiccamera and other surgical tools. However, the actual working angle ofthe tools is ultimately determined by the length and inner diameter ofthe cannula. Heavy patients or patients with large amounts of skin andother tissue covering the joint require a longer cannula to penetratethe tissue sufficiently for the procedure. This increased cannula lengthdecreases the working angle of the tools at the joint, limiting theability of the surgeon to perform the procedure. Although this angle maybe improved by increasing the inner diameter of the cannula, there arerealistic limits on the useable diameter. For example, the diameter canonly be increased by a small amount or else it would effectivelyeliminate any benefit of conducting the arthroscopic procedure as theportal size could become the equivalent of a large incision as performedin traditional surgery.

The aforementioned irrigation fluid and/or gases pumped into a jointduring a surgical procedure must remain sealed within said joint tomaintain sufficient pressure and space for the movement of surgicalinstruments. Various devices and techniques have been employed in theprior art to maintain such seal. Most typically, a series of annularseals mounted within a cannula, at an end of said cannula proximal tothe patient, serve to prevent leakage of fluid out of the joint during asurgical procedure. However, the usage of such annular seals for fluidretention has drawbacks in that undesirable leakage tends to occur assurgical instruments passing through the cannula are manipulated duringa procedure. Further undesired leakage also tends to occur upon theinsertion and/or removal of surgical instruments to/from the cannuladuring a procedure.

What is needed is a surgical portal device that is capable of retractingthe tissue through which it penetrates, that is relatively simple toinsert and remove so as to minimize tissue damage to the patient, thatincludes a novel means for incorporating a shape memory alloy into itsdesign that is easy to store, use, remove, and reuse (or dispose of),and that provides for enhanced fluid retention. The surgical portaldevice disclosed herein satisfies these needs and others as will becomeapparent to one of ordinary skill after a careful study of the detaileddescription and embodiments.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The present invention will be more fully understood by reference to thefollowing detailed description of the preferred embodiments of thepresent invention when read in conjunction with the accompanyingdrawings, wherein:

FIG. 1 is an exploded view of a first embodiment of the cannulainvention;

FIG. 2 is a depiction of the cannula invention prior to insertion of thetrocar device;

FIG. 3 is an assembled view of the embodiment, highlighting a crosssectional area;

FIG. 4 is a cross section of the working end of the invention as in theassembled view of the embodiment;

FIG. 5 is a depiction of an alternative embodiment of the cannulainvention prior to insertion of the trocar device;

FIG. 6 is an assembled view of the alternative embodiment, highlightinga cross-sectional area;

FIG. 7 is a cross section of the working end of the invention as in theassembled view of the alternative embodiment;

FIG. 8 is a cross section of the working end highlighting an alternativedovetail channel shape;

FIG. 9 is a cross section of the working end highlighting an alternativecircular channel shape;

FIG. 10 is a cross section of the working end highlighting analternative embodiment with an embedded material that assists in theopen bias of the fins;

FIG. 11 is an alternative embodiment of the cannula invention with thefins in the open position;

FIG. 12 is a depiction of the process for closing the fins in thealternative embodiment;

FIG. 13 is a depiction of the alternative embodiment of the cannulainvention prior to insertion of the trocar device;

FIG. 14 is a proximal end view depiction of an embodiment of the cannulainvention highlighting penetrations into which a biasing device may beinserted;

FIG. 15 is a proximal end view depiction of another embodiment of thecannula invention highlighting penetrations into which a biasing deviceof an alternate shape may be inserted;

FIG. 16A depicts a side view of a rectangular-shaped embodiment of abiasing device;

FIG. 16B depicts a front view of the rectangular-shaped embodiment of abiasing device;

FIG. 17A depicts a side view of a cylindrical-shaped embodiment of abiasing device;

FIG. 17B depicts a front view of the cylindrical-shaped embodiment of abiasing device;

FIG. 18 depicts a side view of an embodiment of the cannula inventionhighlighting installation of a biasing device;

FIG. 19 depicts a cutaway view of an embodiment of the invention in useduring shoulder surgery;

FIG. 20 a perspective view of a further alternate embodiment of acannula device having cavities formed within to accept insertion ofshafts of a biasing device;

FIG. 21 depicts a side view of the further alternate embodiment of thecannula device as shown in FIG. 20;

FIG. 22 depicts an exploded view of the alternate embodiment of thecannula device shown in FIG. 20 and FIG. 21;

FIG. 23 depicts a perspective view of an alternate embodiment of abiasing device for use insertion into the alternate embodiments of thecannula device shown in FIGS. 20, 21 and 22;

FIG. 24 depicts a perspective view of the alternate embodiment of thebiasing device shown in FIG. 23, when such device is in a phase whereindistal portions of the biasing device's shafts are flexed outward;

FIG. 25 depicts perspective views of the alternate embodiments of thecannula device and biasing device as shown in FIG. 20 and FIG. 23,respectively;

FIG. 26 depicts a side view of the alternate embodiment of the cannuladevice having an alternate embodiment of a biasing device (shown inbroken lines) embedded within cavities formed into the cannula device;

FIG. 27 depicts an exploded view of an alternate embodiment of thecannula device and biasing device as shown in FIG. 26, along with analternate embodiment of a trocar device for use therewith;

FIG. 28 depicts a perspective view of the alternate embodiments on thecannula device (2002) and trocar device (2704) shown in FIG. 27;

FIG. 29 depicts a cutaway view of the alternate embodiment of thecannula device and trocar device as shown in FIG. 28, in use duringshoulder surgery;

FIG. 30 depicts a side view of an alternate embodiment of the cannuladevice having a cannula passageway with a flexible distal opening;

FIG. 31 depicts a top view of the alternate embodiment of the cannuladevice shown in FIG. 30, showing the flexible distal opening of thecannula passageway in a substantially open position;

FIG. 32 depicts a top view of the alternate embodiment of the cannuladevice shown in FIG. 30, showing the flexible distal opening of thecannula passageway in a substantially closed position;

FIG. 33 depicts a perspective view of the alternate embodiments of thecannula device of FIG. 30 mounted to a trocar device;

FIG. 34 depicts a cutaway view of the alternate embodiment of thecannula device and trocar device as shown in FIG. 33, in use duringshoulder surgery;

FIG. 35 depicts a cutaway view of the alternate embodiment of thecannula device as shown in FIG. 34, having a cannula removal toolmounted around the shaft of the cannula to aid in removal of the cannulafrom a patient following shoulder surgery;

FIG. 36 depicts a cutaway view of the alternate embodiment of thecannula device being used in shoulder surgery as shown in FIG. 34, inwhich the cannula removal tool mounted around the shaft of the cannulaaids in straightening the biasing device fins during removal of thecannula from the patient;

FIG. 37 depicts a side view of the alternate embodiment of the cannuladevice and trocar device as shown in FIG. 33, in use during shouldersurgery, and more specifically, at a time just prior to insertion into ashoulder tissue structure;

FIG. 38 depicts a side view of the alternate embodiment of the cannuladevice and trocar device as shown in FIG. 37, in use during shouldersurgery, and more specifically, at a time just following insertion ofthe cannula device and trocar device shaft into a shoulder tissuestructure;

FIG. 39 depicts a side view of the alternate embodiment of the cannuladevice and trocar device as shown in FIG. 37, in use during shouldersurgery, and more specifically, at a time just following insertion ofthe cannula device and trocar device shaft into a shoulder tissuestructure, the cannula removal tool being removed to allow fordeployment of the cannula biasing fins;

FIG. 40 depicts a side view of the alternate embodiment of the cannuladevice and trocar device as shown in FIG. 37, in use during shouldersurgery, and more specifically, at a time just following deployment ofthe cannula biasing fins;

FIG. 41 depicts a side view of the alternate embodiment of the cannuladevice and trocar device as shown in FIG. 37, in use during shouldersurgery on a patient having a higher than average body mass index, andmore specifically, at a time just following deployment of the cannulabiasing fins;

FIG. 42 depicts a side view of the alternate embodiment of the cannuladevice and trocar device as shown in FIG. 37, in use during shouldersurgery, and more specifically, at a time during retraction of thetrocar device;

FIG. 43 depicts a side view of the alternate embodiment of the cannuladevice and trocar device as shown in FIG. 37, in use during shouldersurgery, the cannula device distal opening being compressed by tissuestructures;

FIG. 44 depicts a side view of the alternate embodiment of the cannuladevice and trocar device as shown in FIG. 37, in use during shouldersurgery, a surgical instrument passing through the cannula device, saidcannula device providing for a wide range of movements by the surgeonusing said instrument;

FIG. 45 depicts a side view of the alternate embodiment of the cannuladevice and trocar device as shown in FIG. 37, in use during shouldersurgery, a surgical instrument passing through the cannula device, saidcannula device providing for a wide range of movements by the surgeonusing said instrument;

FIG. 46 depicts a side view showing two alternate embodiments of thecannula device and trocar device as shown in FIG. 37, in use duringshoulder surgery, said cannula devices providing for a wide range ofmovements by the surgeon using surgical instruments;

FIG. 47 depicts a perspective view of a portal holder device having apassageway with a flexible distal opening;

FIG. 48 depicts a side view of the portal holder device shown in FIG.47, showing the flexible distal opening of the portal holder device in asubstantially closed position;

FIG. 49 depicts a top view of the portal holder device shown in FIG. 47,showing the flexible distal opening of the portal holder device in asubstantially closed position;

FIG. 50 depicts an exploded view of the portal holder device as shown inFIG. 47, along with an alternate embodiment of a trocar device for usein device deployment during surgery;

FIG. 51 depicts a perspective view of the portal holder device as shownin FIG. 47, along with an alternate embodiment of a trocar device foruse in device deployment during surgery, the ends of the shafts of theportal holder device secured within notches formed on the end of thetrocar device shaft;

FIG. 52 depicts a side view of an alternate embodiment of the portalholder device removably mounted to a trocar device;

FIG. 53 depicts a side partial view of the alternate embodiment of theportal holder device, deployment plug, and trocar device as shown inFIG. 52;

FIG. 54 depicts a side view of the alternate embodiment of the portalholder device as shown in FIG. 52;

FIG. 55 depicts a side view of the alternate embodiment of the portalholder device as shown in FIG. 52, said device being removably mountedto a cannula;

FIG. 56 depicts a partial perspective view of the alternate embodimentof the portal holder device, deployment plug, and trocar device as shownin FIG. 52;

FIG. 57 depicts an alternate embodiment of a trocar device usable todeploy embodiments of the portal holder device during surgery;

FIG. 58 depicts a side view of a further alternate embodiment of aportal holder device and deployment plug mounted to an embodiment of atrocar device for use during surgery;

FIG. 59 depicts a side view of a further alternate embodiments of portalholder devices removably mounted to opposing sides of an embodiment of atrocar device, for use during surgery;

FIG. 60 depicts a cutaway view of the alternate embodiment of the portalholder device invention as shown in FIG. 52, demonstrating how theshafts may be extended and retracted as desired during shoulder surgery;

FIG. 61 depicts a cutaway view of the alternate embodiment of the portalholder device as shown in FIG. 60, as well as a trocar device used todeploy the device during surgery; and

FIG. 62 depicts a cutaway view of the alternate embodiment of the portalholder device as shown in FIG. 60, having shafts that may be extendedand retracted as desired during shoulder surgery.

The above figures are provided for the purpose of illustration anddescription only, and are not intended to define the limits of thedisclosed invention. Use of the same reference number in multiplefigures is intended to designate the same or similar parts. Furthermore,if and when the terms “top,” “bottom,” “first,” “second,” “upper,”“lower,” “height,” “width,” “length,” “end,” “side,” “horizontal,”“vertical,” and similar terms are used herein, it should be understoodthat these terms have reference only to the structure shown in thedrawing and are utilized only to facilitate describing the particularembodiment. The extension of the figures with respect to number,position, relationship, and dimensions of the parts to form thepreferred embodiment will be explained or will be within the skill ofthe art after the following teachings of the present invention have beenread and understood.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 depicts an exploded view of a first embodiment of the cannulainvention. As shown in this figure, the complete apparatus includes acannula device (102) and a trocar device (104). The trocar device (104)includes a handle (120) at its proximal end with a shaft member (118)extending therefrom to form a distal end with a defined tip (124). Alongthe shaft are multiple raised members (122) that protrude essentiallyradially from the axial center of the shaft (118) and that extendlongitudinally along the shaft length. The raised members (122) in thepresent embodiment are depicted as extending approximately one half ofthe length of the shaft (118) near the distal end. However, the lengthof the raised members (122) may vary in other embodiments. For example,the raised members (122) in another embodiment may be wider than theyare in length. Such alternate lengths are within the scope of thepresent invention. The raised member (122) of the embodiment, asdepicted, is also a single element. However, in another embodiment theraised member may be split in two portions such that, on the whole, theraised member (122) may still engage the corresponding slot.

The present embodiment of the cannula device (102) includes body member(108) having a proximal end and a distal end. The body member (108) isessentially cylindrical in shape, having a lumen extending from end toend. Although the body member in the present embodiment is essentiallycylindrical in shape, other embodiments may have a geometriccross-sectional shape other than circular, or may include a mix ofcircular and other geometric shape such as a circular lumen crosssection with a geometric outer wall cross section or vice versa. Theouter wall may also include a ribbed, grooved, or helical raised feature(or even a recessed feature) that assists the device in gripping apatient's skin and muscle tissue for device retention. Such alternateembodiments are envisioned and are within the scope of the presentinvention.

The proximal end includes a fluid drain port (110) and a proximal collar(114) that retains several silicon discs (112) that are used as fluidseals through which surgical instruments may pass. The proximal collar(114) attaches to the proximal end of the body member for positiveretention of the silicon discs (112). The drain port (110) allows forfluid management during surgical procedures in the same fashion asconventional cannula devices.

The distal end of the body member (108) includes a plurality offlexible, yet semi-rigid fins (106) that are formed in theoutwardly-biased position (as shown in FIG. 1) during injection moldingof the device. The present embodiment utilizes medical grade polymersduring the injection molding or extrusion process. These polymers allowthe fins to retain the outwardly-biased shape at normal operatingtemperatures for the device, yet also allow the fins to flex inwardlywhen sufficient pressure is applied. For example, polyurethanes such asHytrel® or Arnitel® may be utilized due to the desired durabilitycharacteristics, or polyvinyl chloride (“PVC”) if expense is a concern.

Each fin (106) of the present embodiment includes a radius of curvaturethat approximates that of the wall of the body member (108) that formsthe lumen. When the fins (106) are forcibly moved to the inward position(as depicted in FIG. 3), the inner surface of the fins essentiallyextends the lumen of the body member (108) to the distal end of thefins. Further, because the fins have a wall thickness, each fin featuresan edge surface that extends from the fin inner surface to the fin outersurface. It is the edge surface of the fin that contacts the edgesurface of the adjacent fin when the fins are in the inward-mostposition (as in FIG. 3).

FIG. 2 depicts the cannula invention prior to insertion of the trocardevice. As shown, the tip (124) of the trocar device is inserted throughthe cannula device proximal collar (114) such that the raised members(122) engage with complimentary slots formed within the body member(108) of the cannula device. These complimentary slots extend a distancewithin the cannula device lumen and along the edge surfaces of the fins(106). This embodiment features two corresponding slots (126), one foreach fin. Other embodiments may utilize a greater number of fins and,consequently, would require a correspondingly greater number of slots.For example, an embodiment with three outwardly-biased fins would havethree pairs of adjacent fin edge surfaces. Such an embodiment wouldrequire three slots within the cannula body member and threecorresponding complimentary raised members on the trocar device.

FIG. 3 depicts an assembled view of the embodiment as it would beconfigured for use once the trocar device (104) is inserted into thecannula device body member (108). As shown, insertion of the trocardevice (104) engages the slots within the fins (106), causing the fins(106) to move inward against the outward bias pressure that is normallypresent. In the full inward position the edge surfaces of the fins (106)meet. This figure also highlights a cross sectional area, which is shownin detail in FIG. 4.

The cross-section detail depicted in FIG. 4 demonstrates how the trocarshaft member (118) fits within the cannula lumen and engages thecomplementary slots in the fins (106). In this embodiment, the cannuladevice has two fins. Formed within the inner wall of the body member aretwo slots, each having a cross section that resembles a serif fontcapital letter “T”. This slot extends the length of the body memberinner wall and is aligned with the origin of the edge surfaces of thefins (106) as they extend from the body member, and accepts acorresponding serif font capital letter “T” shaped raised member (122)on the trocar.

A corresponding portion of the “T” slot is formed in the wall of eachfin at the junction of the edge surface and the inner surface. When thefins (106) are in the inward most (or “closed”) position (as shown inFIG. 3), the adjoining fin edge surfaces (126) meet and complete theoverall “T” slot such that it extends from the body member to the distalend of the fins. Although the corresponding “T” slot portion in the finedge surfaces (126) extends approximately the entire length of the finin the present embodiment, other embodiments may extend less than theentire length of the fin.

To prepare the embodiment for use with a patient, the trocar device isinserted into the cannula device lumen such that raised members (122)engage the corresponding and complimentary body member “T” slots. As thetrocar shaft (118) is further inserted into the lumen, the raisedmembers slide within the “T” slots until they reach the origin of theedge surfaces of the fins (106). As the trocar is further inserted, theraised members apply stress to the corresponding “tail” elements of “T”slot portions in each fin edge surface (126) causing the fins to moveinward and come together along adjacent edge surfaces. This has theeffect of “zipping” the fin edges together for insertion of the deviceinto a patient.

Although a serif capital “T” shaped slot cross section is discussed,other embodiments may utilize cross-sectional slot shapes that providean elemental feature that positively engages and accepts compressivestresses from the corresponding elements of the raised members to causethe fins to move inward and come together along adjacent edge surfacesas the trocar is inserted. Each fin edge surface may include a slot thatfeatures a cavity that is larger than the opening formed in the edgesurface, with additional material removed from the edge surface where itintersects with the fin inner surface to allow for the correspondingraised member to pass therebetween. For example, the edge surface mayhave a longitudinal slot formed therein that has a dovetailcross-section. The corresponding raised member would include twocorresponding dovetail pin features to engage the adjacent dovetailslots in the adjacent fin edge surfaces. Each fin edge surface may alsoinclude a slot with a formed cavity that turns inward towards the innersurface, outward towards the outer surface, or both, such that the slotopening in the edge surface is not aligned with the deepest portion ofthe slot cavity. For example, the edge surface may have a longitudinalslot that is formed such that cavity beneath the slot opening iscentered toward the inner surface and does not share the exactcenterline of the cavity opening. Again, the trocar device would includea corresponding raised member that engages the slot as before. In yetanother embodiment it is also possible to have a plurality of slots,with each slot having a different geometric cross sectional shape.

FIG. 5 depicts an alternative embodiment of the cannula invention priorto insertion of the trocar device. As shown, the trocar device has ashaft member (510) with raised members (506) and a distal tip (508).However, in this embodiment the corresponding slots (504) in the cannuladevice are formed such that they extend from the proximal opening andalong the inner wall of the body member and along the inner wall of thefins (502) at some point between each fin's edge surface (501).Insertion of the trocar device into the cannula device, once again,causes the flexible outwardly-biased fins (502) to move inward such thatadjacent fin edge surfaces (501) meet and the closed fins essentiallyform an extension of the body member as shown in FIG. 6. In this figure,the device is again ready for insertion into a patient.

FIG. 6 depicts an assembled view of the alternative embodiment,highlighting a cross sectional area. FIG. 7 depicts the cross section ofthis embodiment in which conventional “T” slots (504) are formed in thefin (502) inner walls approximately midway between the edge surfaces.The trocar shaft (510) features raised members (506) that correspondwith each “T” slot. Although the present embodiment depicts a singleslot formed midway between the edge surfaces of each fin, otherembodiments may utilize multiple slots per fin, with appropriate spacingbetween the slots. In such embodiments, the trocar shaft will featurecorresponding raised members that engage the slots. Further, althoughthe present embodiment describes use of “T” slots in the fins, othergeometric slot shapes that afford positive engagement with correspondingraised members may be utilized. For example, FIG. 8 depicts use ofdovetail slots (802) formed in the inner surfaces of the fins (502).Likewise, FIG. 9 depicts use of circular slots (902) formed in the innersurfaces of the fins (502). Still other geometric slot shapes arecontemplated and are within the scope of the present invention. Further,it is possible to combine fin edge surface slots with inner surfaceslots. Such an arrangement may be helpful to more evenly distribute theclosing forces applied to the fins during insertion of the trocar deviceand prevent distortion of the fins.

In yet another embodiment, it is possible to utilize an embedded shapememory alloy as a biasing device, such as but not limited to Nitinol, ineach fin to increase the outward-bias pressure generated by the fins. Byincreasing the outward bias pressure, it is possible to apply additionalcompressive stress to the tissue of the patient through which thecannula device is inserted. FIG. 10 depicts such an embodiment. Asshown, each fin (106) includes an embedded shape memory alloy strip(1002) within the fin wall at some location between the edge slots(126). This embedded shape memory alloy strip may also be used with theembodiments discussed above, and may be incorporated within the wallbeneath or near the respective slot. Further, although the figuredepicts use of a single embedded shape memory alloy (1002) in each fin(106), other embodiments may utilize multiple shape memory alloys atvarious locations spaced within the fin walls. Other biasing devices mayinclude other metals, such as stainless steel, or polymers that exertadded biasing force over that provided by the molded fins solely.Moreover, while the shape memory alloys may be permanently included inthe fins during manufacture, it is also envisioned that the shape memoryalloys may be provided in an insertable/removable form. FIGS. 14 and 15each present an embodiment of the cannula device incorporating such afeature.

In yet another embodiment it is possible to incorporate an additionalalloy with the embedded shape memory alloy to create a bimetallic stripor alter the composition such that it varies, with temperature, the finoutward-bias pressure that is generated. For example, Nitinol may alsobe “tuned” or “trained” to react at different temperatures by addingadditional alloys to its composition. Such a material may be used in thefins of an embodiment to allow the fins to generate greater outward-biaspressures when the fins reach the patient's body temperature.

In other alternate embodiments, integral or removable biasing devicescomposed of shape memory alloys (such as Nitinol) may be embedded intothe fins to generate or supplement outward-bias pressure of varyingdegrees through electrical activation. For example, a biasing devicecomposed of Nitinol may be embedded into one or more fins of a cannuladevice and electrically connected to a voltage differential such thatthe Nitinol forms an electrical circuit. When a current is selectivelypassed through such circuit, the Nitinol biasing device may be trainedto flex outwardly in an amount corresponding to the amount of currentpassing through such biasing device at least partially forming theaforementioned circuit. A pulse width modulation (“PWM”) circuit ispreferably utilized to provide for more even heating of the Nitinolbiasing device. In this manner, the degree to which the Nitinol biasingdevice flexes inward and outward may be selectively controlled by thesurgical team. Such alternate embodiments configured for electricalactivation and in particular, the biasing devices composed of shapememory alloys, should preferably be constructed to include sufficientelectrical insulation such that neither the patient nor the surgicalteam risks being exposed to dangerous electrical current. Electricalcomponents, such as wires, may pass through passages formed in a trocar.Other necessary electrical components needed to provide for electricalactivation of such a biasing device (power supply, switch(es), controlsystems, etc.), may be located remotely from the trocar and cannula orintegrated within such structures.

FIG. 11 depicts an alternative embodiment of the cannula device of thepresent invention. As shown, the cannula device features a body member(1102) with a lumen that exists from the proximal end to the distal end,and a plurality of outwardly-biased fins (1104) extending from thedistal end of the body member. Each fin includes a plurality ofcorrugated features (1110) that extend inward from the outer surface ofthe fin and are formed along the length of the fin. One fin includes alocking feature (1106) at its distal end for capturing the distal end ofthe other fins (1108). The locking feature in this embodiment is aconical portion of the distal end of the fin that allows the distal endof the other fins to be captured beneath.

This embodiment of the device is prepared as shown in FIG. 12. Asdepicted, the fins are physically moved inward such that the adjacentfin edges meet and a fin grouping is formed. The fin grouping is thenbent toward the fin having the locking feature such that the fin withthe locking feature is bent backward as depicted. The relative flexingof the fins in this fashion allows the fins without the locking feature(1108) to be inserted beneath the conical locking feature (1106) suchthat all are captured in the closed position as further depicted in FIG.13.

FIG. 13 depicts the additional elements of this embodiment as well asthe prepared cannula device. As shown, the embodiment includes a trocardevice having a handle (1302) with a shaft member (1306) extending fromthe proximal end to form a tapered distal end (1308). An anti-plungingdevice (1304) attaches to the shaft member (1306), and the tapereddistal end (1308) is inserted into the proximal end of the cannuladevice lumen. The anti-plunging device (1304) blocks the shaft memberdistal end (1308) from advancing past a first position as shown in thefigure by hidden lines in the body member (1102). This first positionprevents the shaft member distal end (1308) from contacting thecorrugated feature (1110) in the fins.

Once assembled, this embodiment may be utilized with a patient byinserting the distal end of the fin into an incision in the patient'sskin. Once the body member (1102) is fully inserted, the anti-plungingdevice (1304) is removed from the shaft (1306) and the trocar is furtherinserted past the first position to a second position. In the secondposition, the tapered distal end (1308) contacts the corrugated features(1110), applying force to the fins such that the captured fins aredislodged from beneath the locking feature (1106). The bias pressures ofthe fins then force the fins to return to the initial outward-biasposition, compressing the patient's tissue through which the cannuladevice was inserted (as in FIG. 19).

FIG. 14 is a proximal end view depiction of an embodiment of the cannulainvention highlighting penetrations (also alternatively referred toherein as “cavities”) into which a biasing device may be inserted. Asshown, the cannula device proximal collar (114) features an additionalrectangular biasing device penetration (1402) for accepting aninsertable biasing device as depicted in FIG. 16. Each penetration(1402) includes a recessed feature (1404) that reduces the amount thatthe inserted biasing device protrudes above the surface of the proximalcollar (114). The embodiment shown includes a plurality of fins (106),each with penetration that runs from the proximal collar surface to anarea beyond the outward bend in the outwardly biased flexible fins(106). In this embodiment in which insertable biasing devices areutilized, it is possible that the biasing forces imparted by the bareflexible fins (106) (no biasing device inserted) can be minimal, whichreduces the inward force necessary to converge the fins for insertion ofthe device into an incision in the skin of a patient.

It is also envisioned that another embodiment may have a plurality offins with less than all fins having a biasing device penetration. Thebiasing device penetrations (1402) may be formed by drilling, machining,reaming, or molding the cannula device, or by any other process known inthe art that is appropriate for the material utilized for constructionof the cannula device. Also, although a rectangular-shaped biasingdevice penetration is shown, other shapes are envisioned. For example,FIG. 15 is a proximal end view depiction of another embodiment of thecannula invention highlighting penetrations into which a biasing deviceof an alternate shape may be inserted. The biasing device penetration(1502) in this figure is circular, but one of ordinary skill to whichthe invention pertains will understand and appreciate that other shapesmay be utilized. For example, it is envisioned that the biasing devicemay utilize a triangular, hexagonal, or octagonal cross section. Arecessed feature (1504) is again shown, and is a shape that correspondsto the proximal head of the insertable biasing device. Further, it isalso envisioned that multiple penetrations may be formed within aflexible fin (106), thereby allowing a given flexible fin (106) withpenetrations to accept one or more insertable biasing devices.

FIGS. 16 and 17 depict two example embodiments of biasing device for theinstant invention. FIG. 16A depicts a side view of a rectangular-shapedembodiment of a biasing device, while FIG. 16B depicts a front view ofthe rectangular-shaped embodiment of the biasing device. Shown is thebiasing device (1600) rectangular shaped body (1604) and an attachedproximal head (1602). The biasing device features a static bend near thedistal end that substantially corresponds to the outwardly biasedflexible fin (106) bend into which the biasing device (1600) is to beinserted. The proximal head (1602) provides a feature that allows anoperator to apply finger pressure to the device (1600) during insertionand removal. The proximal head (1602) also limits the distance thedevice (1600) may penetrate into the biasing device penetration(1402/1404). FIG. 17A depicts a side view of a cylindrical-shapedembodiment of a biasing device, while FIG. 17B depicts a front view ofthe cylindrical-shaped embodiment of the biasing device. The biasingdevice (1700) cylindrical body (1704) has a circular cross section, witha proximal head (1602) and a static bend near the distal end thatsubstantially corresponds to the outwardly biased flexible fin (106)into which the biasing device (1700) is to be inserted.

The cannula device may be prepared by a technician or surgeon prior touse. FIG. 18 is a side view of an embodiment of the cannula inventionhighlighting installation of the biasing device during devicepreparation. The cannula device includes biasing device penetrations(1502)—shown in ghosted lines for clarity—extending from the proximalcollar (114) surface to substantially the distal tip of the fins (106).The technician or surgeon first converges the fins (106) by fingerpressure or trocar and then inserts the distal end of a biasing device(1700) into the penetration (1502) up to the bend and rotates thebiasing device body (1704) inward towards the body member (108) lumenwhile inserting the biasing device (1700) until the proximal head (1702)substantially engages the biasing device recess (1504). Friction betweenthe penetration (1502) wall and the biasing device body (1704) retainsthe biasing device (1700) or, alternately, a textured body surface maybe utilized to cause the biasing device (1700) to be effectivelypermanently retained within the penetration (1502). Following surgery,the biasing device (1700) may be removed from the disposable cannula andsterilized for reuse in another such cannula. Removal of the alloybiasing device (1700) will also allow for proper recycling/disposal of apolymer cannula. Reuse of the biasing device (1700) will also reduce theoverall equipment material costs associated with this cannula device.

The cannula device may also be prepared with additional biasing devices(1700) after the cannula device has been inserted into a patient. Insuch an instance the surgeon, following insertion of the lumen into anincision in the patient's skin, allows the distal tips of the fins (106)to splay outward as the biasing devices (1700) are inserted as before.Thus, the outward biasing force of the fins (106) may be adjusted insidethe patient if necessary. For example, if the retractable cannula fin(106) outward biasing pressure is sufficient without the biasing devices(1700), the biasing devices (1700) may be omitted from the procedure.However, if the patient has an excess of tissue to compress and the fin(106) pressure is inadequate to do so, then one or more biasing devices(1700) may be inserted as above. Further, biasing devices (1700) ofdiffering biasing force (for example, by using different materialgauges, cross sectional shapes, compositions, or the like or somecombination thereof) may be utilized to allow fine-tuning of the fin(106) compressive force.

Once inside a patient, the trocar is removed from the cannula device andthe fins naturally return to their outwardly-biased position. FIG. 19depicts such an event. As shown, the body member (108) forms a port inthe patient's skin and outer tissue (1906) through which surgicalinstruments (1902) may pass. The outwardly biased flexible fins (106) ofthe cannula device exert pressure on the tissue (1906) and assist thesurgeon in compressing the tissue (1906) to allow for a greater workingcavity (1904) and exposure of the surgery site (1908). Because of thecompressive effect of the flexible fins (106) on the tissue (1906), thelength of the body member (108) may be made relatively short compared toconventional cannula devices. This shortened body member (108) resultsin a shortened lumen length that, consequently, allows a greater workingangle (shown on the figure as the Greek letter “a”) for the surgeon'stools (1902), which improves the surgeon's access to the surgery siteand reduces the need for physical manipulation of the cannula duringsurgery. When surgery is complete, the cannula device may be removed byreinserting the trocar device into the lumen such that the trocar raisedmembers engage the slots in the fins and the fins move inward once more.The cannula device may then be withdrawn from the patient with minimaltissue damage. Although the present embodiment is described in useduring shoulder arthroscopy, one of ordinary skill will understand thatthe device may be employed in essentially any arthroscopic,laparoscopic, or other types of endoscopic surgery requiring the surgeonto establish a working port in the tissue of a patient. Moreover, itshould be noted that alternate embodiments of the cannula invention maybe utilized to perform endoscopic surgery on subjects other than humanssuch as, for example, animals such as dogs, cats and livestock. Those ofordinary skill in the art will recognize that the dimensions of thecannula invention will require modification depending upon theanatomical structures of the particular subject of the surgery in whichthe invention is utilized, as wells as the type of endoscopic surgerybeing performed.

Referring now to FIG. 20, a perspective view of a further alternateembodiment of a cannula device (2002). The cannula device (2002)comprises a body member (2008), two fins (2006) and a proximal collar(2014). Longitudinal cavities (2010) formed into the fins (2006) providea passage through which a biasing device (not shown) may be embedded.While the biasing devices of the preferred embodiments described hereinare removably insertable into the cannula device, it is contemplatedthat alternate embodiments may include biasing devices that areintegrally embedded into the cannula device. The proximal collar (2014)retains discs used to provide a seal through which surgical instrumentsmay pass. Referring now to FIG. 21, a side view of the further alternateembodiment of the cannula device (2002) as shown in FIG. 20. The cannula(2002) is constructed of medical grade polymer and includes flexiblefins (2006) that are neutral with respect to their outward and inwardbiasing pressure. In even further alternate embodiments, the cannula maybe at least partially composed of polymers constructed to provide thefins with an outward biasing pressure at normal temperatures as has beendescribed with respect to the embodiments of the cannula discussedabove. Referring now to FIG. 22, an exploded view of the alternateembodiment of the cannula device (2002) shown in FIG. 20 and FIG. 21. Asilicone rear gate seal (2012) is attached to the proximal collar (2014)and provides a retaining structure to secure the one or more insertablebiasing devices (not shown) within the cannula device (2002) during use.A silicone spacer (2013) is attached to the proximal collar (2014) at alocation proximal to the silicone rear gate seal (2012).

Referring now to FIG. 23, a perspective view of an alternate embodimentof a biasing device (2302) for use in the alternate embodiments of thecannula device shown in FIGS. 20, 21 and 22. The biasing device (2302)is comprised of two elongated shafts (2303) joined at their respectiveproximal ends by a circular collar (2304). The shafts of the biasingdevices shown in FIG. 23 are generally rectangular in the cross-section.However, as has been noted above, alternate embodiments of biasingdevices may include shafts having cross sections of various shapes. Thebiasing device is composed at least partially of a shape memory alloysuch as Nitinol, allowing a user to “train” the biasing devices to takeon a desired form.

Referring now to FIG. 24, a perspective view of the alternate embodimentof the biasing device shown in FIG. 23, when such device is in a phasewherein distal portions of the biasing device's shafts are flexedoutward. The biasing devices may be composed of materials and “trained”to provide for such outward flexing at desired temperatures. Forexample, the biasing device may be trained to exhibit such outwardflexing upon encountering temperature approximating typical human bodytemperatures. As previously discussed, biasing devices composed of shapememory alloy(s) may be electrically activated to exhibit such flexing inamounts corresponding to electrical current passed through such biasingdevices. While the shafts of the biasing device shown in FIG. 23 andFIG. 24 have shafts with at least portions that are in a substantiallyparallel configuration with respect to one another, it is contemplatedthat in alternate embodiments, the biasing devices will include shaftsconfigured to converge towards one another at a predetermined angle,before flexing outwardly. In such embodiments, the convergence of thebiasing device shafts may provide, at the convergence point, a fluidretention seal. Such embodiments are discussed below with reference toFIGS. 37-45.

Referring now to FIG. 25, perspective views of the alternate embodimentsof the cannula device (2002) and biasing device (2302) as shown in FIG.20 and FIG. 23, respectively. Both the cannula device (2002) and biasingdevice (2302) are configured to mate with one another, allowing a userto insert the biasing device into the cannula device through cavityopenings in the cannula device formed into the proximal collar (similarto the penetrations (1504) shown at FIG. 15 and FIG. 18).

Now referring to FIG. 26, a side view of the alternate embodiment of thecannula device (2002) having an alternate embodiment of a biasing device(2302) (shown in broken lines) embedded within cavities (or“penetrations”) formed into the cannula device (2002). The distal ends(2303) of the shafts of the biasing device protrude beyond the distalends of the cannula device such that when the fins (2006) are releasedfrom the trocar device and flex outward, the distal ends (2303) of thebiasing device will retreat into the cannula (not protrude as shown inFIG. 26). Further, the protruding nature of the distal ends (2303) ofthe shafts of the biasing device also provide a structure which may beremovably secured to the distal end of a trocar device shaft (via anotch formed onto the distal head of the trocar shaft, said notch shapedto receive and removably secure the distal end of the biasing deviceshaft), thus keeping the biasing shafts and cannula fins fromprematurely flexing outwardly. When activated, through heat, electricalcurrent, or other means, the shafts of the biasing device are configuredto flex outwardly, causing the fins (2006) of the cannula to also flexoutwardly. Such outward flexing, when the cannula is inserted into thesurgical site, assists the surgeon in both compressing the patient'stissue, and further providing a larger working cavity.

Referring now to FIG. 27, an exploded view of an alternate embodiment ofthe cannula device (2002) and biasing device (2302) as shown in FIG. 26,along with an alternate embodiment of a trocar device (2704) for usetherewith. The trocar device (2704) serves the purpose of both providinga mechanism for physically placing the cannula device (with embeddedbiasing device) at the surgical site, and also serves to release thebiasing device from the inward pressure applied by the shaft (2705) ofthe trocar device, which is integrally or in some alternate embodiments,removably attached to a distal end of the trocar handle member. Notches(2726) formed on the distal end or “shaft head” (2724) of the trocardevice shaft (2705) are shaped to receive and removably secure thedistal ends of the shafts of the biasing device (2302). The distal endsof the biasing device shaft may be inserted into the notches (2726)formed on opposite sides of the distal end of the trocar device. It iscontemplated that in alternate embodiments of the surgical devicedeployment tool, other types of receiving member, sized and shaped toreceive correspondingly sized and shaped structures of a surgicalinstrument, may be utilized. For example, in addition to notches, suchreceiving members may include apertures, latche(s), holes, a hood, andchannels. In other alternate embodiments, the receiving members maycomprise electromagnets sized to engage and secure biasing membersand/or fins having ferrous materials. Embodiments of the trocar deviceor other surgical device deployment tool may release the fins of thecannula devices and portal holder devices (see below) via a mechanicalrelease mechanism or by an electronic release mechanism. For example,with respect to a mechanical release, a movable spring-loaded releaselatch located on the distal end of the trocar device may be actuatedfrom a trigger or button located in the trocar device handle(mechanically linked through the trocar shaft) to cause the release ofthe fins by actuation of the latch. When inserted into the notches, thedistal ends of the biasing devices are prevented from flexing outwardly.The trocar device may be constructed of any number of polymers or othermaterials having rigid or semi-rigid properties. A “c” shaped spacer(2713) is shaped and sized to be removably secured around the proximalend of the trocar device shaft (2705), such that it is located betweenthe distal end of the trocar device handle member (2720) and theproximal collar of the cannula device when the trocar device is attachedto said cannula. The spacer (2713) serves to prevent the prematuredeployment of the biasing device shafts and cannula fins until the timedesired by the surgical team. When the spacer (2713) is removed from thespace between the distal end of the trocar device handle (2720) and theproximal collar of the cannula, the trocar device may then be moved in adistal direction (generally towards the patient when the cannula hasbeen inserted into a patient), decreasing the gap between said handleand the proximal collar, such that the distal ends of the biasing deviceshafts are disengaged from the notches (2726), allowing said shafts andthe cannula fins to flex outwardly. In this manner, a surgeon may deploythe fins of the cannula at a desired time during a surgical procedure.

Referring now to FIG. 28, a perspective view of the alternateembodiments on the cannula device (2002) and trocar device (2704) shownin FIG. 27. The shaft of the trocar device (2704) is shown inserted intoan opening (not shown) in the proximal end of the cannula device suchthat the distal end (2724) of the trocar shaft protrudes from the distalend of the cannula device. The distal ends (2303) of the biasing devicelikewise protrude beyond the end of the cannula device. Theconfiguration of the cannula device and trocar device shown in FIG. 28demonstrate the appearance of such devices prior to insertion into apatient. It should be noted that the distal ends of the biasing deviceshafts are not shown inserted into the notches (2726) in the drawingshown at FIG. 28. The “c” shaped spacer (2713) is removably securedbetween the distal end of the trocar device handle and the proximalcollar of the cannula. Following completion of the surgery, the biasingdevice may be returned to its inward phase (through use of thermal orelectrical control, or through use of the trocar device) and the trocardevice may be used to remove the cannula from the surgical site. Thecannula may alternatively be removed without use of a trocar device,utilizing methods discussed above or as known in the art.

Referring now to FIG. 29, showing a cutaway view of the alternateembodiment of the cannula device and trocar device as shown in FIG. 28,in use during shoulder (2906) surgery. The cannula device (2002) hasbeen inserted into the patient's shoulder through use of the trocardevice (2704). At the appropriate time, the surgical team may remove the“c” shaped spacer (2713) from the trocar device, allowing the trocardevice to be moved distally toward the patient. As the cannula devicewill remain generally stationary during such movement of the trocardevice, the distal ends of the biasing device shafts (2302) will slideout of the notches securing them to the end of the trocar device shaft.Once the distal ends of the biasing device shafts are no longer securedin the notches, said shafts (2302) and the cannula fins (2006) will befree to flex in an outward direction as shown in FIG. 29. The flexiblefins (2006) of the cannula device assist the surgical team incompressing the patient's tissue (1906) so that a greater working cavity(2904) is formed, providing better exposure of the surgery site (2908).The outward flexing of the cannula fins also works to put increasedpressure on the ports and other cavities inside the cannula. Suchincreased pressure on the ports and other cavities inside the cannuladevice aids in creating tighter seals between the cannula device andother surgical instruments passing through the cannula device, leadingto less fluid leakage during surgery.

Referring now to FIG. 30, showing a side view of a further alternateembodiment of the cannula device with a body member (2002) having acannula passageway with a flexible distal opening (3002) for aiding influid retention during surgical procedures. In the embodiment of thecannula device appearing at FIG. 30, the cannula walls bifurcateapproximately halfway between the ends of the cannula. The bifurcatedcannula walls serve as flexible fins (2006) that may be outwardly biasedwith the use of one or more types of biasing devices. In thisembodiment, the cannula walls are bifurcated but in other embodiments,the cannula walls could be trifurcated, or split into a plurality ofother fins. Also, while the embodiment shown in FIG. 30 illustrates acannula device bifurcated approximately halfway between the ends of thecannula, the location of the bifurcation (or number of splits) could belocated along other points in the length of the cannula, depending onthe desired length of fins, which could be based on a number of factorsincluding, but not limited to, the type of surgery, the anatomy of thepatient, the type of tissue around the surgical site, and the type ofsurgical instruments that would need to traverse the cannula opening. Inone embodiment, a cannula for surgical procedures comprises a bodymember having walls forming a lumen along at least a proximal portion ofa length of said body member, said walls being bifurcated at two or morepoints along said length to form a plurality of distally extendingflexible fins, wherein said fins are naturally biased in an outwarddirection, and wherein said walls are flexible such that, followinginsertion into a patient during a surgical procedure, at least a portionof said walls are compressed inwardly to form a substantiallyimpermeable seal of said lumen.

Outwardly flexing fins (2006) of the cannula device exert a biasingpressure that provides for a more favorable surgical environment.Specifically, as previously described, the outwardly biased flexiblefins (2006) of the cannula device exert pressure on the tissue andassist the surgeon in compressing the tissue to allow for a greaterworking cavity and exposure of the surgery site. In one embodiment, oneor more biasing devices are embedded within at least a portion of eachof the fins of the cannula device. In one embodiment, the distal tips ofthe one or more biasing devices protrude from distal ends of each of theflexible fins. In one alternate embodiment, a biasing device (2302)(shown in broken lines) is embedded within cavities formed into thecannula device (2002). The biasing device may be integrally formedwithin the cannula device so as to be non-removable. Alternatively, thebiasing device may be configured to be removable, allowing for theutilization of biasing devices having different material properties orhaving been “trained” in various manners to perform certain tasks moreefficiently for certain procedures, or for certain patient body typesand tissue dimensions. As previously discussed, the biasing devices maybe composed of any number of materials but are preferably, in thisalternate embodiment, composed of a shape memory alloy such as Nitinol.When activated, through heat, electrical current, or other means, theshafts of the biasing device composed of a shape memory alloy, areconfigured to flex outwardly, causing the fins (2006) of the cannula toalso flex outwardly and provide the aforementioned favorable surgicalsite in that it provides for enhanced visualization of the site for thesurgeon.

Still referring to FIG. 30, a flexible opening (3002) is positioned onthe cannula device (2002) at approximately the convergence of thecannula fins (2006) with the main cannula body. A substantially tubularaperture which in one embodiment, is approximately 4 millimeters indiameter, and runs longitudinally down a portion of the shaft of thecannula body, having a proximal opening adjacent the proximal collar(2014) or “base” of the cannula, and terminating at the flexible opening(3002). The flexible opening (3002) serves as a substantiallyimpermeable seal for fluid retention during surgical proceduresinvolving the use of irrigation fluid or gases pumped into the surgicalsite. The flexible opening provides for such a substantially impermeableseal by preferably maintaining a substantially closed state such thatthe inner walls of the cannula opening are compressed upon one another.Although the term “seal” is used herein, it is contemplated that suchseal will allow for the passage of surgical instruments and other toolsused in surgery. As used herein, the terms “substantially impermeable”or “substantial fluid retention” do not mean absolute impermeability orsealing effect, but instead means that while some leakage is possibleand expected, such leakage does not substantially interfere with thesurgical procedure being undertaken with such cannula device. Further,the term “fluid” is not only intended to encompass traditional fluidmaterials (saline solution, blood, etc.), but also gases and othermaterials used in surgical procedures or that may otherwise emanate froma patient during surgery. As used herein, the terms “substantiallyimpermeable seal” further contemplates that some acceptable amount offluid leakage may occur with the traversing of surgical instrumentsthrough such seal.

Although the flexible opening (3002), which is located at convergencepoint of the plurality of fins, preferably naturally maintains a closedconfiguration, it is also capable of expansion into an open state (asshown in FIG. 30) or semi-open state, allowing for the passage ofsurgical instruments or other devices used during surgical procedures,while still providing for sufficient fluid retention. In one embodiment,the flexible opening is positioned along the length of the shaft of thecannula body at a location that, when a portion of the cannula isinserted into a patient during a surgical procedure, will be inside thepatient near the surgical site itself. This positioning of the flexibleopening within the patient at the surgical site, provides fluidretention related advantages not realized in prior art cannula devices.Namely, such a configuration provides for enhanced fluid/gas retentionin that the substantially impermeable seal provided by the flexibleopening, prevents the leakage of fluids/gases outside of the surgicalsite itself, and substantially decreases the amount of fluid/gas thatcan enter into the proximal portions of the cannula body. In oneembodiment, the substantially impermeable seal is located distal to thepoints at which the walls of the cannula bifurcate to form the flexiblefins. In alternate embodiments, the substantially impermeable seal isformed proximal to the points at which the walls of the cannulabifurcate to form the flexible fins.

Referring now to FIG. 31, depicting a top view of the alternateembodiment of the cannula device (2002) shown in FIG. 30, showing theflexible distal opening of the cannula passageway in a substantiallyopen position. As noted above, although the flexible opening (3002)preferably maintains a naturally closed position, the walls of theopening are flexible in that the material used to construct the opening,which may or may not be in alternate embodiments the same material usedto construct the main cannula body, is capable of being opened tovarying diameters (although the opening is not necessarily shaped in acircular manner). By providing for this capability, the flexible openingprovides for the passage, through the cannula body, of surgicalinstruments and other devices used in surgical procedures. In contrastto prior art cannula devices, the cannula configuration described hereinadvantageously provides for the passage of surgical instruments ofvarious sizes, through a relatively small opening that maintainssufficient fluid retention at the surgical site.

Referring now to FIG. 32, depicting a top view of the alternateembodiment of the cannula device shown in FIG. 30, showing the flexibledistal opening (3002) of the cannula passageway in a substantiallyclosed position. In the substantially closed position shown in FIG. 32,the inner walls of the cannula are compressed upon one another at such aforce that an adequate seal is created so as to provide for fluid/gasretention during surgery, but not so much force so as to prevent therelatively easy insertion and removal of surgical instruments throughthe flexible opening. In one embodiment, the cannula body, including theflexible opening, may be constructed of a polymer material that providesfor sufficient rigidity and flexibility to be utilized in the mannerdescribed herein. In other embodiments, the flexible opening may becomposed of a different material than that which is used for otherportions of the cannula body, providing for a more flexible material tobe used for the flexible opening.

In other alternate embodiments of the cannula device, the flexibleopening may be modular in nature and comprise a removable insert forinstalling and positioning inside the lumen of a cannula device. Aflexible opening, configured for removable insertion into a cannulabody, would provide further advantages over the prior art in thatflexible openings of different dimensions, different shapes, and havingdifferent fluid retention properties, could be selected by a surgeonbased on a particular surgical application. In one alternate embodiment,the removable flexible opening may be configured having an outer body ina substantially circular shape for insertion in a cannula device havinga correspondingly shaped inner shaft, and abutting inner walls providinga seal for substantial fluid retention. In such an alternate embodiment,the removable flexible opening may be configured to be installed via thedistal end of the cannula device such that the outwardly flexing fins(2006) may provide space for easy insertion into the main cannula shaft.In one such embodiment, grooves may be formed on the outer walls of theflexible opening, configured to engage corresponding raised members onthe inner wall of the cannula lumen intended to engage the modularflexible opening. It is contemplated, with respect to the alternateembodiment discussed in this paragraph and throughout thisspecification, that structures other than the abutting inner wallsdescribed herein, could be utilized to provide for the substantial fluidretention sought during surgical procedures.

Referring now to FIG. 33, depicting a perspective view of the alternateembodiments of the cannula device (2002) of FIG. 30 mounted to a trocardevice (2704). The shaft of the trocar device is shown inserted into anopening (not shown) in the proximal end of the cannula device (2002)such that the distal end (2724) of the trocar shaft protrudes from thedistal end of the cannula device. The distal ends of the biasing deviceprotrude beyond the end of the cannula device. The configuration of thecannula device and trocar device shown in FIG. 33 demonstrate theappearance of such devices prior to insertion into a patient. It shouldbe noted that the distal ends of the biasing device shafts are not showninserted into the notches (2726) in the drawing shown at FIG. 33. A “c”shaped cannula removal tool (2713) is removably secured between thedistal end of the trocar device handle and the proximal collar (2014) ofthe cannula.

Referring now to FIG. 34, depicting a cutaway view of the alternateembodiment of the cannula device and trocar device as shown in FIG. 33,in use during shoulder surgery. The cannula device (2002) has beeninserted into the patient's shoulder through use of the trocar device(2704). At the appropriate time, the surgical team may remove the “c”shaped spacer and cannula removal tool (2713) from the trocar device,allowing the trocar device to be moved distally toward the patient. Asthe cannula device will remain generally stationary during such movementof the trocar device, the distal ends of the biasing device shafts(2302) will slide out of the notches securing them to the end of thetrocar device shaft. Once the distal ends of the biasing device shaftsare no longer secured in the notches, said shafts (2302) and the cannulafins (2006) will be free to flex in an outward direction as shown inFIG. 34. The flexible fins (2006) of the cannula device assist thesurgical team in compressing the patient's tissue (1906) so that agreater working cavity (2904) is formed, providing better exposure ofthe surgery site (2908). The flexible opening (not shown), positionedduring surgery within the patient and directly adjacent to the surgicalsite, provides for enhanced fluid/gas retention during the surgicalprocedure.

Referring now to FIG. 35, depicting a cutaway view of the alternateembodiment of the cannula device (2002) as shown in FIG. 34, having a“c” shaped cannula removal tool (2713) mounted around the shaft of thecannula to aid in removal of the cannula from a patient followingshoulder surgery. At the termination of surgery, or at any time it isdesirable to remove the cannula device, the cannula removal tool may bemounted on the outer body of the cannula device and used to apply inwardpressure on the biasing fins (2006) to aid in removal from the patient.In one embodiment, the cannula removal tool (2713) is configured in a“c” shape to engage the proximal end of the shaft of the trocar deviceand, as previously described herein, to be employed during thedeployment of the cannula device from the trocar so as to release theoutwardly biased fins. In one embodiment, the cannula removal tool(2713) includes an integrally attached handle for aiding in the removalof the tool from the trocar device, and also to aid in the removal ofthe cannula device from the patient.

Referring now to FIG. 36, depicting a cutaway view of the alternateembodiment of the cannula device (2006) being used in shoulder surgeryas shown in FIG. 34, in which the cannula removal tool (2713) is mountedaround the shaft of the cannula as it aids in straightening the cannulafins (2006) during removal of the cannula from the patient. In oneembodiment, the cannula device (2006) may be removed from the patient,utilizing the cannula removal tool (2713), by mounting the tool on theouter cannula body, grasping and gently pulling the cannula away fromthe patient, while at the same time sliding the tool in a distaldirection down the cannula body towards the patient. The tool thusdepresses against the patient's skin as the cannula is slowly removed,and at the same time causes the fins (2006) to be inwardly biased, whichfurther eases the removal of the cannula device. It is contemplated thatin other alternate embodiments, the cannula removal tool may be shapedand sized in various alternate forms that will further enhance theability of the tool to assist in removal of the cannula.

Referring now to FIGS. 37-46, shown are side views of the alternateembodiment of the cannula device and trocar device as shown in FIG. 33,in use during shoulder surgery. In particular, FIG. 37 depicts a partialside view of the alternate embodiment of the cannula device and trocardevice as shown in FIG. 33, in use during shoulder surgery, and morespecifically, at a time just prior to insertion into a shoulder tissuestructure. In FIG. 37, the fins (2006) of the cannula (bifurcatedcannula walls) and embedded biasing devices (2302) are mounted on atrocar, although here only the trocar shaft (2705) and distal head(2724) are shown. In its non-deployed state, the distal tips of thebiasing device are secured within notches in the head (2724) that aresized to receive them until the time of deployment. Still referring toFIG. 37, a cross-sectional view of a patient (3701) is shown adjacent tothe distal end of the cannula device and trocar. Various layers ofpatient tissue (3707) is shown adjacent to a surgical site (3709). Anincision point (3705) in the patient is shown, which forms one end of apassageway the cannula/trocar device must pass to access the surgicalsite.

FIG. 38 depicts a side view of the alternate embodiment of the cannuladevice and trocar device (partial view) as shown in FIG. 37, in useduring shoulder surgery, and more specifically, at a time just followinginsertion of the cannula device and trocar device shaft into a shouldertissue structure. The cannula device remains in its deployed stateduring such insertion. FIG. 39 depicts a side view of the alternateembodiment of the cannula device and trocar device (partial view) asshown in FIG. 37, in use during shoulder surgery, and more specifically,at a time just following insertion of the cannula device and trocardevice shaft into a shoulder tissue structure, the cannula removal toolbeing removed to allow for deployment of the cannula biasing fins. Theremoval of the c-shaped tool (2713) from the trocar shaft (2705) leavesa space between the proximal end of the cannula device and the distalend of the trocar handle. This space provides for rearward movement(away from the patient) of the cannula device along the trocar shaft(2705), while the head of the trocar (2724) remains substantiallyunmoved, allowing for the deployment of the fins. As the cannula movesrearward during the deployment process, so do the distal tips of thebiasing devices, allowing them to free themselves from the notches towhich they were secured in the non-deployed state. Once the distal tipsof the biasing devices are no longer secured within the notches on thehead of the trocar device, the fins naturally flex outward away from thetrocar shaft.

FIG. 40 depicts a side view of the alternate embodiment of the cannuladevice and trocar device as shown in FIG. 37, in use during shouldersurgery, and more specifically, at a time just following deployment ofthe cannula biasing fins. Once deployed, the fins of the cannula devicework to compress the patient's tissue, allowing for a shorter lumenlength of the cannula. FIG. 41 depicts a side view of the alternateembodiment of the cannula device and trocar device as shown in FIG. 37,in use during shoulder surgery on a patient having a higher than averagebody mass index, and more specifically, at a time just followingdeployment of the cannula biasing fins. The flexible fins (2006) act tocompress the additional tissue of the patient, resulting in a shortenedlumen length. As discussed elsewhere herein, this is an advantage notseen in surgical cannulas of the prior art because this shortened lumenlength allows a greater working angle for the surgeon's tools, which inturn provides for better access to the surgery site, and reduces theneed for physical manipulation of the cannula during surgery. Becausethe non-bifurcated portion of the cannula is shorter, hence a shorterlumen length, the advantage discussed above is most substantial whenperforming surgery on patients having a greater amount of fat tissue, asthe flexible fins work to compress such tissues that would otherwiselead to a lessened range of movements during surgery (because a greaterlumen length would be required). The patient's tissue also acts tocompress the flexible opening (3002) of the cannula, which allows theinner walls of the cannula to act as a barrier to fluid movement,providing a substantially impermeable seal for fluid retention duringsurgery. This ability of the flexible opening to serve as asubstantially impermeable seal during surgery provides an additionaladvantage not provided by prior art cannulas.

FIG. 42 depicts a side view of the alternate embodiment of the cannuladevice and trocar device (partial view) as shown in FIG. 37, in useduring shoulder surgery, and more specifically, at a time duringretraction of the trocar device. Following deployment of the cannulafins, the trocar device may be extracted in a rearward movement (awayfrom patient), allowing for the insertion of other surgicalinstruments/tools into the cannula. FIG. 43 depicts a side view of thealternate embodiment of the cannula device and trocar device as shown inFIG. 46, in use during shoulder surgery, the cannula device distalopening being compressed by tissue structures. The c-shaped tool (2713)may be used by the surgeon to remove the cannula device from the patientby using it to compress the tissue and the fins as the cannula is beingremoved.

Referring now to FIG. 44, depicted is a side view of the alternateembodiment of the cannula device and trocar device as shown in FIG. 37,in use during shoulder surgery, a surgical instrument (4401) passingthrough the cannula device, said cannula device providing for a widerange of movements by the surgeon using said instrument. FIG. 45 depictsa side view of the alternate embodiment of the cannula device and trocardevice as shown in FIG. 37, in use during shoulder surgery, a surgicalinstrument (4401) passing through the cannula device, said cannuladevice providing for a wide range of movements by the surgeon using saidinstrument. Referring now to FIG. 46, depicted is a side view showingtwo alternate embodiments of the cannula device and trocar device asshown in FIG. 37, in use during shoulder surgery, said cannula devicesproviding for a wide range of movements by the surgeon using multiplesurgical instruments (4401; 4403).

The features of the cannula device discussed above allow the cannuladevice to be constructed with an outer diameter less than prior artcannulas and thus, decreased cross-sectional area. In one embodiment,the outer diameter of the cannula device is approximately eightmillimeters. The reduced cross-sectional area of the cannula devicesprovides several advantages as compared to prior art cannula devices.For example, one advantage of a decreased cross-sectional area is areduction in tissue trauma during surgery. Another advantage of thecannula device invention is that such cannulas do not require exteriorthreading for retaining the cannula as do many prior artcannulas—primarily because they are unnecessary because the cannula finssecure the cannula to the patient's tissue. An even further advantage ofthe cannula device invention is that it provides for increasedvisualization during surgery as compared to prior art cannula devices.

Referring now to FIGS. 47-59, depicted are views of several embodimentsof portal holder devices (and associated trocar and other devices whichaid in deployment during surgery) which, in many respects, servefunctions similar in nature to the cannula devices discussed hereinabove, but consist only of one or more flexible fins or shafts thatalone or in combination with other fins/shafts, act to serve as both aconduit for surgical instruments during surgery, and also provide foradequate fluid retention during surgery. Various different embodimentsof the portal holder device are shown and described herein.

Referring now to FIG. 47, depicted is a perspective view of a portalholder device (4702) having a passageway with a flexible distal opening.In one embodiment, the portal holder device (4702) comprises twoflexible fins (4703) joined by a conical like collar (4714) at aproximal end. The flexible fins, in one mode when not secured by atrocar device, naturally flex outwardly in an arc-like fashion,converging at a point (4704) distal to said collar. In one embodiment ofthe portal holder device, the flexible fins are constructed of a shapememory alloy such as Nitinol and, as explained above, may be trained(shape memory) to take on various shapes at predetermined temperatureranges. In other embodiments, the fins of the portal holder device maybe constructed of other materials having flexible properties while alsoproviding spring-like/biasing properties in the sense that they causethe fins to provide an outwardly projecting force for tissue retraction.In one embodiment, a hole (4716) formed in the collar (4714) provides aconduit or passageway through which surgical instruments and other toolsused during surgery may pass during surgery. The aforementioned collarhole (4716) also provides a conduit through which a trocar device shaftmay pass for engaging the distal ends of the portal device holder finsas discussed further below. Although the collar is conical in shape inthe figures described herein, it is contemplated that other embodimentsof the portal holder device will incorporate collars have other shapessuch as, for example, a collar having an oval shaped cross-section.Other alternate embodiments of the portal holder device may alsoincorporate two or more fins of various lengths, depending upon theparticular surgical application for which the device will be intended.Alternate embodiments of the portal holder device may employ alternategeometries by which the two or more fins may converge to provide forboth fluid retention and tissue retraction. In alternate embodiments ofthe portal holder device, as described below, the collar hole may bethreaded to receive a correspondingly threaded deployment plug which mayaid in deploying the fins when at the surgical site.

Referring now to FIG. 48, depicted is a side view of the portal holderdevice (4702) shown in FIG. 47, showing the flexible distal opening ofthe portal holder device in a substantially closed position. In oneembodiment, the portal device holder fins converge at a point (4704)distal to the collar (4714), approximately a third of the way along thelength of the fins, as measured from the collar to the distal tips ofsaid fins. The length of the fins in alternate embodiments may vary,depending upon the particular surgical application and the particularanatomy of the patient. Likewise, the fins of the portal holder devicemay be configured to converge at other locations along the length of thefins, and at different distances from the collar and/or distal tips ofthe fins—again such modifications will depend on the type of surgicalapplication and the patient's anatomy, as well as the types of surgicalinstruments and other tools that are intended to pass through the portalholder device. Still referring to FIG. 48, the convergence point (4704)serves as a barrier to fluid leakage during surgical procedures and likeembodiments of the cannula device discussed herein, creates asubstantially impermeable seal when patient tissues further compress theconvergence point once the device is deployed. The fins are configured(through shape memory training techniques or otherwise) to maintain aninwardly directed force against one another, providing such fluidleakage barrier. The principals discussed with reference to FIGS. 37-46,showing a patient's tissue bearing upon the cannula convergence point toprovide a fluid seal, are equally applicable with respect to theoperation and advantages of the portal device holder. Specifically, itis contemplated that during surgery, a patient's tissue will assist theportal device holder in pressing inwardly to provide a fluid barrier.Although the embodiment of the portal holder device depicted anddiscussed herein includes two fins, as noted above, it is contemplatedthat alternate embodiments of the portal device holder will include twoor more fins of various geometries, various fin lengths, and connectionconfigurations, to provide both a conduit for surgical instruments, aswell as fluid retention and tissue retraction during surgery. Forexample, one alternate embodiment of the portal device holder mayinclude three fins intertwined in a helical shaped configuration,wherein the twisting nature of the helical configuration can, at certainportions of the device, converge to provide for a fluid retentionbarrier. Utilization of shape memory alloys in constructing and“training” the fins allows for such alternate fin geometries andinterconnectedness.

Referring now to FIG. 49, depicted is a top view of the portal holderdevice (4702) shown in FIG. 47, showing the flexible distal opening(4704) of the portal holder device in a substantially closed position.While the convergence point (4704) of the portal holder device (4702) isclosed in the embodiment of the device shown at FIG. 49, those of skillin the art will understand that the fins (4703) are flexible, allowingfor surgical instruments and other tools to pass forward and rearwardbetween the fins as needed with minor application of force by thesurgeon. The flexibility of the fins of the portal holder device allowfor a wide range of movements of instruments by the surgeon, in the samemanner depicted in FIGS. 44-46 with respect to the cannula device taughtherein.

Referring now to FIG. 50, depicted is an exploded view of the portalholder device (4702) as shown in FIG. 47, along with an alternateembodiment of a trocar device (2704) for use in device deployment duringsurgery. The trocar device (2704) serves the purpose of both providing amechanism for physically placing the portal holder device at thesurgical site, and also serves to release the fins of portal holderdevice. Notches (2726) formed on the distal end (2724) of the trocardevice shaft (2705) are shaped to receive and removably secure thedistal ends of the fin shafts of the portal holder device (4702). Thedistal ends of the fins of the portal holder device may be inserted intothe notches (2726) formed on opposite sides of the distal end of thetrocar device. When inserted into the notches, the distal ends of theportal holder device are prevented from flexing outwardly. The trocardevice may be constructed of any number of polymers or other materialshaving rigid or semi-rigid properties. A “c” shaped spacer/removal tool(2713), which also serves as a removal device, is shaped and sized to beremovably secured around the proximal end of the trocar device shaft(2705), such that it is located between the distal end of the trocardevice handle (2720) and the proximal collar of the cannula device whenthe trocar device is attached to said cannula. The spacer/removal device(2713) serves to prevent the premature deployment of the fins (4703)until the time desired by the surgical team. When the spacer (2713) isremoved from the space between the distal end of the trocar devicehandle (2720) and the collar of the portal holder device, the trocardevice may then be moved in a distal direction (generally towards thepatient when the portal holder device has been inserted into a patient),and/or the portal device may be moved in a rearward direction (away frompatient) while keeping the trocar device unmoved, decreasing the gapbetween said handle and the proximal collar, such that the distal endsof the portal holder device fins are disengaged from the notches (2726),allowing said fins to flex outwardly. In this manner, a surgeon maydeploy the fins of the portal device holder at a desired time during asurgical procedure.

Referring now to FIG. 51, depicted is a perspective view of the portalholder device (4702) as shown in FIG. 47, along with an alternateembodiment of a trocar device for use in device deployment duringsurgery, the ends of the shafts of the portal holder device securedwithin notches formed on the end of the trocar device shaft. The shaftof the trocar device (2704) is shown inserted into an opening (notshown) in the proximal end of the portal holder device such that thedistal head (2724) of the trocar shaft protrudes from the distal end ofthe portal holder device. The configuration of the portal holder deviceand trocar device shown in FIG. 51 illustrate the appearance of suchdevices prior to insertion into a patient and deployment of the portalholder device. The “c” shaped spacer/removal device is removably securedbetween the distal end of the trocar device handle and the collar (4714)of the portal holder device.

Referring now to FIG. 52, a further alternate embodiment of the portalholder device (5202), removably mounted to a trocar device (2704), isshown. While other embodiments of the portal holder device discussedabove included flexible fins having proximal ends secured to a collar,in the alternate embodiment shown in FIG. 52, the proximal portions ofthe flexible fins are movably secured to the base (or “collar”),distally and proximally, allowing for the working lengths of the fins(the length of the fins from the proximal end of the collar to thedistal tips of the fins) to be varied by the surgeon as desired. In theembodiment shown in FIG. 52, the proximal portions of the fins (adjacentto the collar (5214)) are secured to the collar by relatively shortslots (5216, 5218) formed on outer walls of both sides of the collar.The slots (5216, 5218) are sized to receive the fins and allow them topass through, such that the proximal portions of the fins can protrudepast the proximal end of the collar. The slots are sized to provideenough friction that the fins will not move while experiencing forcestypical during surgery. However, the slots are sized such that a surgeoncan apply enough force to extend and retract the fins, allowing thesurgeon to choose not only the working length of the fins, but theconvergence point of the fins. This feature provides an additionaladvantage (beyond fluid retention and tissue compression) not seen inprior art cannulas in that a surgeon can make such modifications to thedimensions of the portal holder device on the fly during surgery asconditions warrant. It will be recognized that the distance between thedistal end of said base member and a convergence point between saidshafts, may be varied by a user by increasing or decreasing the workinglength of said biasing devices. Likewise, it will also be recognizedthat the width of a gap between the shafts of the biasing devices, at aconvergence point (where the gap between the shafts is narrowest) may bevaried by a user by increasing or decreasing the working length of saidbiasing devices.

Still referring to FIG. 52, the alternate embodiment of the portalholder device shown is in many respects similar to the embodiment shownin FIG. 51. A shaft (5205) and distal head (2724) of a trocar device(2704) is configured to pass through the collar or “base member” (5214)and fins (5203) of the portal holder device (5202). Notches (not shown)formed on the distal head of the trocar device (2724) are sized toreceive the distal tips of the portal holder device prior to beingdeployed during surgery. A deployment plug or tool (5220) having a holethrough which the shaft (5205) passes, is removably mounted to thetrocar device. The deployment tool (5220) has a distal end that isthreaded and sized to be received in a correspondingly sized andthreaded aperture formed on the inner wall of the collar. A user of thedevice may rotate the deployment tool, causing the portal holder deviceto move rearward (away from distal head of trocar device) andultimately, allow the distal tips of the fins to disengage from thenotches securing them to the trocar device. In this manner, the fins maybe deployed and flex outward. In one embodiment, the portal holderdevice is a surgical device for providing soft tissue compression andfluid retention during surgical procedures, said device comprising abase member having an aperture extending from a proximal end to a distalend; and a plurality of flexible biasing devices attached to said base(or “collar”), said biasing devices having shafts distally extendingfrom said base, wherein said shafts are naturally biased in an outwarddirection, wherein said biasing devices are flexible such that,following insertion into a patient during a surgical procedure, at leasta portion of said shafts are compressed inwardly to form a substantiallyimpermeable seal.

Referring now to FIG. 53, a side partial view of the alternateembodiment of the portal holder device, deployment tool, and trocardevice as shown in FIG. 52. In this embodiment, the fins (5203) (in oneembodiment, comprising a shape memory alloy) of the portal device can bemore easily seen to pass through the notches (5216, 5218) formed on theouter walls of the collar (5214) through which passes the shaft (5205)of the trocar device (2704). As previously described herein, the slotsserve to secure the fins to the collar while allowing movement(extension and retraction) with an application of the requisite amountof force by the surgeon (or other person such as, for example, a nurseor physician's assistant prepping the device for surgery). In alternateembodiments, the proximal ends of the fins may be coated with a softmaterial such as rubber or other polymer to prevent any damage frominadvertent contact with the tips of said fins. Those of skill in theart will recognize that structures, other than notches, may be used tomovably secure the fins to the collar in alternate embodiments of theportal holder device. Likewise, in other alternate embodiments, theproximal portions of the fins may pass through the body of the collarinstead of remaining on the outside of the collar as shown in FIG. 53.The collar may also be constructed in various other shapes in alternateembodiments of the portal holder device. In one embodiment, thedeployment tool (5220) mounted to the trocar device but is free torotate about the axis of the trocar shaft (5205). A structuralobstruction (not shown) may be placed on the threads (5222) of thedeployment tool to act as a stop limiting the travel of the deploymenttool (5220).

Referring now to FIG. 54, shown is a side view of the alternateembodiment of the portal holder device (5202) that appears in FIG. 52.The flexible fins (5203) of the portal holder device (5202) have anaturally outward curve and are, in one embodiment, constructed of ashape memory alloy. While a sizable gap exists between the fins (5203)of the portal holder device shown in FIG. 54, it is contemplated thatthe fins may be formed such that the gap can be of greater or lesserwidth than what is shown. Further, because the fins are capable of beingextended and retracted, the working length of the fins may be modifiedand the gap width likewise modified. Both of the foregoing modificationsmay be desired, depending on a number of factors such as the type ofsurgery being performed, the anatomy of the patient (for example, widthof tissue to traverse to access surgical site), and the types ofinstruments and other tools which are intended to pass through the gapbetween the fins.

Referring now to FIG. 55, a side view of the alternate embodiment of theportal holder device as shown in FIG. 52, said device being removablymounted to a scope cannula, is shown. This figure is shown to illustratethat in alternate embodiments of the portal holder device, the devicemay be mounted on device other than the trocar devices previouslydiscussed herein. Now referring to FIG. 56, shown is a partialperspective view of the alternate embodiment of the portal holderdevice, deployment plug, and trocar device as shown in FIG. 52. Thedistal tips of the fins (5203) of the portal holder device, when in anon-deployed state, may be temporarily secured within a hood formed onthe distal head of the trocar device (2726). As previously discussedhere in connection with other embodiments of cannula devices and portalholder devices, the fins are deployed when movement of the portal holderdevice with respect to the trocar device, cause the distal tips of theportal holder device to be dislodged from the distal end of the trocardevice. Referring to FIG. 57, an alternate embodiment of a trocar deviceusable to deploy embodiments of the portal holder device during surgery.

Referring now to FIG. 58, a side view of a further alternate embodimentof a portal holder device (5802) and deployment tool (5820) mounted toan alternate embodiment of a trocar device for use during surgery. Inthis alternate embodiment, the proximal end of the collar (5814) tapersoutward, away from the axis defined by the trocar device shaft (5805).This outward tapering, adjacent to the most proximal notch (5818),causes the proximal portion of the fin to be deflected away from theproximal opening (not shown) of the collar. In this manner, the degreeof possible unwanted contact by the fins (for example, with the hands ofthe surgeon and/or surgical instruments) is decreased. Referring now toFIG. 59, shown is a side view of further alternate embodiments of portalholder devices removably mounted to opposing sides of an alternateembodiment of a trocar device, for use during surgery. It may bedesirable, in some surgical procedures, to deploy portal holder deviceson opposite sides of the surgical site. Portal holder devices mounted onopposing sides of a modified trocar device may be used in suchsituations.

Referring now to FIG. 60, depicted is a cutaway view of an embodiment ofthe portal holder device invention in use during shoulder surgery. Onceinside a patient, the trocar is removed from the portal holder deviceand the fins naturally flex to their outwardly-biased position. FIG. 42depicts such an event. As shown, the portal holder device (5202) forms aportal in the patient's skin and outer tissue (6006) through whichsurgical instruments (6002) may pass. The outwardly biased flexible fins(5203) of the portal holder device exert pressure on the tissue (2006)and assist the surgeon in compressing the tissue (2006) to allow for agreater working cavity (6004) and exposure of the surgery site (6008).Because of the compressive effect of the flexible fins (5203) on thetissue (6006), the length of the portal holder device may be maderelatively short compared to conventional cannula devices. Thisshortened working length of the fins results in a shortened passage waythrough the portal holder device that, consequently, allows a greaterworking angle (shown on the figure as the Greek letter “a”) for thesurgeon's tools (6002), which improves the surgeon's access to thesurgery site and reduces the need for physical manipulation of thecannula during surgery. Incisions may vary in size from a quarter of aninch to an inch depending upon the application. This device also haslarger scale applications for “mini-open” surgery. This would utilizethe same concept without the arthroscope or laparoscope. Although thepresent embodiment is described in use during shoulder arthroscopy, oneof ordinary skill will understand that the device may be employed inessentially any arthroscopic, laparoscopic, or other types of endoscopicsurgery requiring the surgeon to establish a working port in the tissueof a patient. Moreover, it should be noted that alternate embodiments ofthe portal holder device invention may be utilized to perform endoscopicsurgery on subjects other than humans such as, for example, animals suchas dogs, cats and livestock. Those of ordinary skill in the art willrecognize that the dimensions of the portal holder device invention willrequire modification depending upon the anatomical structures of theparticular subject of the surgery in which the invention is utilized, aswells as the type of endoscopic surgery being performed. The devices inmethods described herein may be utilized in numerous types of surgeriesincluding, but not limited to, surgeries associated with the knee, hip,and elbow, as well as the spine and anywhere surgeons are accessing thebody. In spine surgery, the minimally invasive instruments currentlyused generally utilize a guidewire which is a metallic small-diameterpin. A cannulated obturator could be obtained inserted over the guidepin with the attached biasing fins in a very similar fashion. Similarbenefits of the devices and methods taught herein exist for opensurgery. Using an obturator with or without a guidepin for localizationto insert the retraction device allows for very low-profile insertionand enhanced retraction. It should be noted that while the portal holderdevice is not shown in FIGS. 37-46, the concepts illustrated in suchfigures, including the means by which the portal holder device isinserted, deployed, works to retract and compress tissue once deployedto provide better access to the surgical site and a wider range ofmovement by the surgeon, and provides fluid retention, are equallyapplicable to the embodiments of the portal holder device describedherein.

Once the distal ends of the fins/shafts are no longer secured in thenotches, said fins (5203) will be free to flex in an outward directionas shown in FIG. 61 and FIG. 62. The flexible fins of the portal holderdevice assist the surgical team in compressing the patient's tissue(6006) so that a greater working cavity is formed, providing betterexposure of the surgery site (6008). The flexible opening, positionedduring surgery within the patient and directly adjacent to the surgicalsite, provides for enhanced fluid/gas retention during the surgicalprocedure.

Referring now to FIG. 61, depicting a cutaway view of the embodiment ofthe portal holder device (5202) as shown in FIG. 54. At the terminationof surgery, or at any time it is desirable to remove the portal holderdevice, a c-shaped removal tool (not shown) may be mounted on the outerbody of the portal holder device and used to apply inward pressure onthe fins (5203) to aid in removal from the patient. In one embodimentpreviously described, the removal tool is configured in a “c” shape toengage the proximal end of the shaft of the trocar device and, aspreviously described herein, to be employed during the deployment of theportal holder device from the trocar so as to release the outwardlybiased fins.

Referring now to FIG. 62, depicting a cutaway view of the embodiment ofthe portal holder device (5202) being used in shoulder surgery as shownin FIG. 60. In one embodiment, the portal holder device (5202) may beremoved from the patient, utilizing a c-shaped removal tool (not shown)by mounting the tool on the outer surface of the portal holder device,grasping and gently pulling the device away from the patient, while atthe same time sliding the tool in a distal direction down the portalholder device body towards the patient. It is contemplated that the finsmay also be retracted, as previously described herein and thereby aid inremoval of the portal holder device from the patient.

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The presentembodiments are therefore to be considered in all respects asillustrative and not restrictive. Accordingly, the scope of theinvention is established by the appended claims rather than by theforegoing description. All changes that come within the meaning andrange of equivalency of the claims are embraced therein. Further, therecitation of method steps does not denote a particular sequence forexecution of the steps. Such method steps may therefore be performed ina sequence other than that recited unless the particular claim expresslystates otherwise.

I claim:
 1. A surgical device for providing soft tissue compression andfluid retention during surgical procedures, said surgical devicecomprising: a base member having an aperture extending from a proximalend to a distal end; and a plurality of flexible biasing devicesattached to said base, said biasing devices having shafts distallyextending from said base, wherein said shafts are naturally biased in anoutward direction, wherein said biasing devices are flexible such that,following insertion of at least a portion of said device into a patientduring a surgical procedure, at least a portion of said shafts arecompressed inwardly to form a substantially impermeable seal.
 2. Thesurgical device of claim 1, wherein each of said plurality of flexiblebiasing devices comprises a shape memory alloy.
 3. The surgical deviceof claim 1, wherein proximal portions of each of said plurality offlexible biasing devices are movably secured to said base, allowing aworking length of said biasing devices to be increased and decreased. 4.The surgical device of claim 3, wherein one or more slots formed onouter sides of said base are sized to receive and movably secure saidplurality of biasing devices.
 5. The surgical device of claim 3, whereinsaid proximal end of said base is outwardly tapered.
 6. The surgicaldevice of claim 1, substantially impermeable seal permits the passage ofone or more instruments used in said surgical procedure.
 7. The surgicaldevice of claim 3, wherein a distance between said distal end of saidbase member and a convergence point between said shafts, may be variedby a user by increasing or decreasing the working length of said biasingdevices.
 8. The surgical device of claim 3, wherein a width of a gapbetween said shafts at a convergence point may be varied by a user byincreasing or decreasing the working length of said biasing devices.